510(k) K781891
K781891 is an FDA 510(k) premarket notification submitted by Hillwood Corp. for the device "PIPETTES, PLASTIC DISPOSABLE". The FDA issued a decision of Substantially Equivalent on November 15, 1978. The device falls under product code GJG (Pipette, Quantitative, Hematology), a Class I device regulated under 21 CFR 864.6160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1978
- Date Received
- November 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Quantitative, Hematology
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type